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Maharashtra adds 17,680 MT bulk drug capacity under PLI scheme towards strengthening India's API self-reliance
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Shardul Nautiyal, Mumbai
August 07 , 2026
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India has strengthened its efforts to reduce dependence on imported pharmaceutical raw materials with Maharashtra creating an annual manufacturing capacity of 17,680 metric tonnes (MT) across three projects under the production linked incentive (PLI) scheme for bulk drugs, according to official sources.
Developed with an investment of Rs. 159 crore, the projects form part of the Centre's broader strategy to build domestic manufacturing capabilities for critical active pharmaceutical ingredients (APIs), key starting materials (KSMs) and drug intermediates (DIs), which are essential for ensuring uninterrupted pharmaceutical production and improving the country's health security.
The development comes as the Government of India (GoI) continues to expand domestic production capacities to address supply chain vulnerabilities that became evident during the Covid-19 pandemic. At the national level, 38 projects covering 28 notified products have already been commissioned under the PLI scheme for bulk drugs, creating an annual manufacturing capacity of approximately 56,800 MT. According to the government, these capacities are progressively reducing India's dependence on imports from a single source country for several critical pharmaceutical ingredients.
Officials said India's pharmaceutical industry has historically relied on imported APIs and intermediates, particularly from one dominant overseas supplier, exposing domestic drug manufacturers to supply disruptions and price volatility. The pandemic highlighted the strategic risks associated with excessive import dependence for essential pharmaceutical ingredients, prompting the Government to accelerate measures aimed at strengthening domestic manufacturing.
To address this structural challenge, the GoI launched the PLI scheme for the promotion of domestic manufacturing of critical KSMs, drug intermediates and APIs with a budgetary outlay of Rs. 6,940 crore. The scheme was designed to incentivise local production of 41 identified critical APIs, KSMs and intermediates that were largely imported, thereby improving supply chain resilience and supporting long-term pharmaceutical self-reliance.
Officials noted that the manufacturing capacities established under the scheme are helping create a more diversified domestic supply base for critical drug inputs while reducing import vulnerability. They said the commissioning of projects across different states reflects steady progress in strengthening India's pharmaceutical manufacturing ecosystem and enhancing the availability of essential raw materials required for drug production.
The GoI has also announced the Biopharma SHAKTI scheme with a financial outlay of Rs. 10,000 crore over five years to further strengthen the country's biopharmaceutical sector. Officials said the initiative aims to build a globally competitive ecosystem for biologics and biosimilars while supporting affordable healthcare and positioning India as a global hub for biopharmaceutical manufacturing and innovation.
According to officials, the Biopharma SHAKTI scheme will focus on promoting research and development, strengthening clinical trial infrastructure and encouraging collaboration between academia, research institutions and industry. These measures are expected to improve domestic innovation capabilities and expand manufacturing capacity in advanced biopharmaceutical products, complementing the progress made under the PLI scheme for bulk drugs.
Industry experts believe that increasing domestic production of APIs and key intermediates is essential for strengthening India's pharmaceutical supply chain and ensuring long-term stability. They note that reducing dependence on imported raw materials not only improves the resilience of domestic drug manufacturing but also enhances India's ability to respond to future public health emergencies without significant disruptions in the supply of essential medicines.
Meanwhile, the Department of Pharmaceuticals (DoP) has received representations from several approved beneficiaries under the PLI scheme for Bulk Drugs seeking an extension of the scheme's tenure. However, Government officials clarified that no extension has been approved. According to the DoP, extending the scheme would provide an unfair advantage to beneficiaries who failed to meet the prescribed implementation timelines and would be against the interests of companies that completed their projects within the stipulated schedule.
Officials emphasised that adherence to project timelines remains an important principle of the scheme, ensuring a level playing field for all participating companies while maintaining the credibility of the incentive framework. They added that the government remains focused on strengthening domestic pharmaceutical manufacturing through timely implementation of approved projects and complementary initiatives aimed at building a resilient and globally competitive pharmaceutical sector.
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